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PharmaShots | Your partner in biopharma & healthcare insights. Connecting decision-makers & brands through sharp news, impactful insights and leader interviews
Noida, Uttar Pradesh, India
Joined July 2018
Johnson & Johnson Reports the US FDA’s sNDA Acceptance & Priority Review of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) #jandj #akeega #metastaticcastrationsensitiveprostatecancer #niraparib #hrralterations #amplitude
https://t.co/lVjmPEkufq
pharmashots.com
Shots: The US FDA has accepted sNDA & granted priority review to Akeega (niraparib & abiraterone acetate tablet) + prednisone to treat adults with BRCA-mutated mHSPC sNDA was backed by P-III (AMPLI...
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MSD Unveils P-III (KEYNOTE-B96/ENGOT-ov65) Trial Findings on Keytruda for Platinum-Resistant Ovarian Cancer #merck #keynoteb96 #engotov65 #phase3 #keytruda #platinumresistantovariancancer #clinicaltrial #esmo2025 #rejoiceovarian01 #mk3475
https://t.co/hIdnIGfwBd
pharmashots.com
Shots: Merck has reported P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda (400mg, IV, Q6W for ~2yrs.) with CT ± Avastin vs PBO + CT ± Avastin in Pt-resistant recurrent ovarian cancer pts...
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LEO Pharma Reports the NMPA’s NDA Acceptance for Anzupgo (Delgocitinib) to Treat Chronic Hand Eczema (CHE) #leopharma #anzupgo #delgocitinib #nmpa #chronichandeczema #phase3 #delta1 #delta2 #regulatory #jte052 #leo124249 #lp0133 #nda #deltachina
https://t.co/wIr5z3ouht
pharmashots.com
Shots: China’s NMPA has accepted NDA of Anzupgo cream (delgocitinib) for treating mod. to sev. chronic hand eczema (CHE) in adults, who had an inadequate response or are unamenable to topical...
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Leads Biolabs and Dianthus Therapeutics, Inc. Enter ~$1B Licensing Deal to Jointly Advance LBL-047 #leadsbiolabs #dianthustherapeutics #lbl047 #dnth212 #bispecificfusionprotein #autoimmunediseases #pharma #licensingdeal
https://t.co/CVDVaRHZad
pharmashots.com
Shots: Leads Biolabs has granted Dianthus exclusive global rights to develop, manufacture, & commercialize LBL-047 as DNTH212 outside of Greater China As per the deal, Dianthus will get $20M upfront,...
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EVOQ Therapeutics Enters ~$500M Partnership with Sanofi to Advance NanoDisc Technology #evoq #sanofi #nanodiscplatform #licensingdeal #immunology #autoimmunedisorders #celiacdisease #type1diabetes #mogadantibodydisease #rheumatoidarthritis #lupus #pharma
https://t.co/zSUpYZ47Mo
pharmashots.com
Shots: EVOQ Therapeutics has entered into a collaboration & license agreement with Sanofi to advance EVOQ’s NanoDisc tech in immunology As per the deal, both companies will jointly lead research...
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Biocon Biologics and Civica Rx Partner to Launch Private-Label Insulin Glargine in the US #bioconbiologics #civica #insulinglargine #uscommercialization #diabetes #biosimilar #calrx
https://t.co/ghRXXAdcXi
pharmashots.com
Shots: Biocon Biologics has expanded its strategic collaboration with Civica to commercialize Insulin Glargine in the US Biocon Biologics & Civica entered into a multi-year exclusive distributorship...
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Incyte Reports the Health Canada’s Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD) #incyte #opzelura #ruxolitinib #regulatory #atopicdermatitis #truead3 #piii #igats #thejaad #incb018424 #healthcanada #approval
https://t.co/gPqaD2WCp1
pharmashots.com
Shots: Health Canada has approved Opzelura cream 1.5% for the treatment of mild to mod. AD in children (≥2yrs.), when other topical therapies are ineffective or unsuitable Approval was based on the...
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Eli Lilly and Company Reveals Topline Data from P-III (ACHIEVE-2 & 5) Trials of Orforglipron for Type 2 Diabetes #elililly #piii #achieve2 #achieve5 #orforglipron #type2diabetes #achieve4 #owl833 #ly3502970 #obesity #clinicaltrial
https://t.co/8adR5LbTq4
pharmashots.com
Shots: The 2 P-III (ACHIEVE-2 & 5) trials assessed orforglipron (3, 12 & 36mg; QD) vs dapagliflozin (10mg; QD) in 962 adults with T2D uncontrolled on metformin, & vs PBO in 546 adults with T2D...
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Novartis Highlights P-III (APPLAUSE-IgAN) Trial Findings on Fabhalta (Iptacopan) for IgA Nephropathy #novartis #fabhalta #iptacopan #iganephropathy #applauseigan #piii #vanrafia #atrasentan #zigakibart #egfrdecline #lnp023
https://t.co/gZYEljSD0H
pharmashots.com
Shots: Novartis has reported the P-III (APPLAUSE-IgAN) trial findings assessing Fabhalta (200mg; BID; PO) vs PBO, both on top of SoC in 477 adults with IgA nephropathy (IgAN) Trial showed that...
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Boehringer Ingelheim and AimedBio Collaborate to Advance an ADC Therapeutic in Oncology #boehringeringelheim #aimedbio #adc #oncology #cancer #nbetherapeutics #licensingdeal #pharma
https://t.co/FgYEBeOon2
pharmashots.com
Shots: BI has entered into a global collaboration & licensing agreement with AimedBio to develop a novel ADC for a broad range of cancers, expanding NBE Therapeutics’ portfolio (BI subsidiary) As per...
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Novo Nordisk Signs ~$2.1B Deal with Omeros Corporation to Advance Zaltenibart for Rare Blood & Kidney Disorders #novonordisk #omeros #zaltenibart #oms906 #piii #paroxysmalnocturnalhemoglobinuria #masp3inhibitor #kidneydisorders #licensingdeal #pharma
https://t.co/f4wmTUDr9G
pharmashots.com
Shots: Novo Nordisk has entered into a definitive asset purchase & license agreement with Omeros to develop zaltenibart (MASP-3 inhibitor) for rare blood & kidney disorders, while Omeros retains...
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Vara Reports CE Mark Approval of its Breast Imaging AI for Independent Second Reading of Mammography #vara #breastimaging #ai #cemark #independentsecondreader #screening #diagnostics #praim #medtech #naturemedicine #mammogram #mammography #varaplatform
https://t.co/rN4FwugNqf
pharmashots.com
Shots: Vara has received the European CE Mark approval for its breast imaging AI to operate as an independent second reader for both screening & diagnostic use, with EU availability starting Oct 15,...
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insitro and Bristol Myers Squibb Collaborate to Advance Drug Discovery for Amyotrophic Lateral Sclerosis #insitro #bms #collaboration #ai #amyotrophiclateralsclerosis #chemml #drugdiscovery #pharma #smallmolecule #machinelearning
https://t.co/nim8sSezn3
pharmashots.com
Shots: insitro & BMS have extended their 5yr. collaboration (2020) to discover novel small molecule therapies for ALS using insitro’s AI-enabled ChemML platform The 1yr. extension will focus on...
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Corcept Therapeutics Reports the EMA’s MAA Submission of Relacorilant to Treat Platinum-Resistant Ovarian Cancer #corcept #relacorilant #platinumresistantovariancancer #ovariancancer #usfda #pdufa #piii #rosella #pii #ema #grantagonist #cort125134 #maa
https://t.co/76hJYXWfIY
pharmashots.com
Shots: The EMA has received MAA of relacorilant for the treatment of Pt-resistant ovarian cancer MAA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated...
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BioCryst Pharmaceuticals, Inc. to Acquire Astria Therapeutics, Inc. in ~$700M Cash-and-Stock Transaction #biocryst #astria #navenibart #piii #alphaorbit #atopicdermatitis #star0310 #immunology #ma #qls215 #star0215 #hereditaryangioedema
https://t.co/bM0lrA18ZZ
pharmashots.com
Shots: BioCryst Pharmaceuticals has entered into a definitive agreement to acquire Astria Therapeutics, strengthening its allergic & immunology portfolio As per the deal, Astria shareholders will...
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Pfizer Reports Topline P-III (HER2CLIMB-05) Trial Data of Tukysa (Tucatinib) in Metastatic Breast Cancer (MBC) #pfizer #tukysa #tucatinib #her2climb05 #piii #clinicaltrial #trastuzumab #pertuzumab #tki #metastaticbreastcancer #arry380 #ont380 #mk7119
https://t.co/wcznWRpYfw
pharmashots.com
Shots: Pfizer has reported P-III (HER2CLIMB-05) trial data assessing Tukysa (n=326) vs PBO (n=328), both in combination with trastuzumab & pertuzumab, as a maintenance therapy for pts with HER2+ MBC...
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Boehringer Ingelheim and Click Therapeutics, Inc. Reveal P-III (CONVOKE) Trial Data on CT-155 for Schizophrenia #boehringeringelheim #clicktherapeutics #piii #convoke #clinicaltrial #ct155 #schizophrenia #enspirus #bi3972080 #digihealth #cainsmap # https://t.co/O6wEpeHuOy
pharmashots.com
Shots: The P-III (CONVOKE) trial assessed CT-155 (BI 3972080) vs a digital control app as an adjunct to SoC antipsychotic therapy in pts (≥18yrs.) with experiential negative symptoms of schizophrenia...
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Nabla Bio Partners with Takeda to Advance AI-Driven Protein Therapeutics Design #nablabio #collaboration #takeda #ai #protein #jointatomicmodel #denovoantibody #pharma
https://t.co/suVvaFKPq3
pharmashots.com
Shots: Nabla Bio has entered into a multi-year research collaboration with Takeda to advance AI-driven design of protein therapeutics, leveraging Nabla Bio’s Joint Atomic Model (JAM) Nabla Bio will...
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SystImmune Reports First Patient Dosing in P-II/III (IZABRIGHT-Breast01) Trial of Iza-Bren to Treat Triple Negative Breast Cancer (TNBC) #systimmune #izabren #pii #piii #blb01d1lung101 #izabrightlung01 #nsclc #urothelialcancer #bms #blb01d1 #bms986507
https://t.co/lKNAzrIL9G
pharmashots.com
Shots: SystImmune has dosed the first patient with izalontamab brengitecan (iza-bren) in the global P-II/III (IZABRIGHT-Breast01) study for previously untreated TNBC ineligible for anti-PD-(L)1 drugs...
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GSK Reports the NMPA’s Approval of Shingrix to Protect Individuals Against Shingles #gsk #shingrix #recombinantzostervaccine #shingles #nmpa #regulatory #herpeszoster #gsk1437173a #gsk137173 #qs21
https://t.co/SH4GRQ1q8b
pharmashots.com
Shots: China’s NMPA has approved Shingrix (Recombinant Zoster Vaccine) for the prevention of shingles (herpes zoster) in adults (≥18yrs.) at increased risk due to immunodeficiency or immunosuppress...
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